Evolution® Biliary Stent System-Fully Covered

Evaluation for the Effectiveness of Evolution® Biliary Stent System-Fully Covered

NCT02104076•Cook Group Incorporated

Summary

The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered when used in palliation of malignant neoplasms in the biliary tree.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Inoperable malignant neoplasm causing biliary obstruction or stricture that requires a fully covered metal stent

Exclusion Criteria

•\< 18 years of age
•Unwilling or unable to sign and date the informed consent
•Unwilling or unable to comply with the follow-up schedule
•Undergone or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources
•Participating in another investigational drug or device study in which patient has not completed the follow-up phase for the primary endpoint at least 30 days prior to enrollment
•Endoscopic procedures are contraindicated
•Current anatomy upstream of intended stent placement compromising the flow of bile from the liver such that stent placement may not alleviate the biliary obstruction symptoms
•Presence of a metal biliary stent
•Presence of an esophageal or duodenal stent
•Hypersensitivity/allergy or contraindication to any component of the stent, delivery system, or medication required to complete the procedure,which in the investigator's opinion cannot be adequately premedicated
+7 more criteria

Locations (12)

University of Colorado Hospital

Aurora, Colorado, United States

Borland-Groover Clinic

Jacksonville, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Indiana University Hospital

Indianapolis, Indiana, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

University of Virginia Health System

Charlottesville, Virginia, United States

St. Michael's Hospital

Toronto, Ontario, Canada

Centre Hospitalier de 1'Université

Montreal, Quebec, Canada

Hôpital Edouard Herriot

Lyon, France

Key Dates

Start Date

September 1, 2014

Primary Completion Date

July 1, 2016

Completion Date

January 4, 2017

Last Updated

July 5, 2017

Enrollment

ACTUAL participants

Conditions

Carcinomas/Neoplasms

Interventions

Evolution® Biliary Stent-Fully Covered

DEVICE